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NCT05196919 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of XT-150 for Facet Joint Osteoarthritis Pain
A Phase 2 study, sponsored by Xalud Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 75
- Enrollment target
NCT05196919: Completed Phase 2 study, sponsored by Xalud Therapeutics.
NCT05196919 is a Phase 2 study that has completed, run by Xalud Therapeutics. The registered enrollment target is 75 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05196919, a Phase 2 study, has completed, sponsored by Xalud Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 75 participants
- Enrollment target
Study Summary
This is a Phase 2a safety and efficacy study of XT-150 in adult participants experiencing back pain due to inflammation of the facet joint, also known as facet joint osteoarthritis (FJOA), and who are eligible for intra articular glucocorticoid injection, or radiofrequency ablation of medial branches of the primary dorsal ramus of the exiting nerve root, which innervates the adjacent facet joints. Study drug will be administered at Day 0 and Day 90 by bilateral intra-articular (IA) injection into the facet capsule, at the affected spinal level (e.g. Lumbar \[L\]3-4, L4-5, or L5-Sacrum \[S\]1) as determined by imaging (e.g., Magnetic resonance imaging \[MRI\], Computed tomography \[CT\]), X-ray, etc.) and physical exam. Up to 72 participants will be randomized to placebo or one of two dose treatment groups (24 participants per treatment group). 1. 0.15 mg XT-150 (1.0 milliliter \[mL\] total delivered by two 0.5 mL injections) 2. 0.45 mg XT-150 (1.0 mL total delivered by two 0.5 mL injections) 3. Placebo (Sterile saline) (1.0 mL total delivered by two 0.5 mL injections)
Primary Outcome
Adverse events were collected from the time of informed consent through the last study visit on Day 270 (9 months). Treatment Emergent Adverse Events (TEAEs) occurred from the time of study drug treatment on Day 0 through end of study (Day 270) or early termination.
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL XT-150
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2022-02-24 |
| Est. Completion | 2023-09-20 |
| Phase | Phase 2 |
What the finished NCT05196919 record still lists
NCT05196919 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05196919 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05196919 about?
NCT05196919 is a clinical study titled "Safety and Efficacy of XT-150 for Facet Joint Osteoarthritis Pain". This is a Phase 2a safety and efficacy study of XT-150 in adult participants experiencing back pain due to inflammation of the facet joint, also known as facet joint osteoarthritis (FJOA), and who are eligible for intra articular glucocorticoid injection, or radiofrequency ablation of medial branche...
What is the current status of trial NCT05196919?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 75 participants. The study started on 2022-02-24. Estimated completion is 2023-09-20.
What interventions are being tested in trial NCT05196919?
The interventions under investigation include: Placebo (BIOLOGICAL), XT-150 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05196919?
This trial is sponsored by Xalud Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05196919's enrollment target sits among peer trials
75 900th of 2000 higher than 1,081 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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